Active — Not RecruitingNot Applicable

APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults.

Germany, Ireland, Italy180 participantsStarted 2022-09-22

Plain-language summary

The APPETITE Trial aims to investigate the efficacy of innovative plant protein fibre (PPF) products (developed in a previous workpackage) as part of a personalised diet with/out physical activity on appetite and incidence of undernutrition in older persons from three European countries at high risk of undernutrition.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Community-dwelling, * Age 65+ years, * BMI 19.5-30.4kg/m2, * Inactive (\<150 minutes of moderate to vigorous physical activity per week and no regular resistance training), * Have proof of Covid-19 vaccination Exclusion Criteria: * Major cognitive impairment (MMSE ≤24), * Uncontrolled Clinical depression (CES-D \>16), * Medical condition or current medication known to impact appetite or energy intake, * Other medical condition that may impact ability to participate in study or study outcomes, * Heavy smoker (\>10/day), * Plans to relocate out of the study area within the next 6 months, * Inability to come to study centre/PA program location, * Currently participating in another intervention study, * Inability to participate in physical activity, * Unable to walk across a room, * Allergic to or unwilling to consume any of the study test foods, * Loss of taste or smell associated with COVID-19, * Unwilling to be randomised to any intervention group.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ad libitum energy intake (kcal)

Timeframe: To be assessed at baseline and following a 12-week intervention or control period

Changes in subjective appetite sensations

Timeframe: To be assessed at baseline and following a 12-week intervention or control period

Trial details

NCT IDNCT05608707

SponsorUniversity College Dublin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-17

View on ClinicalTrials.gov More Appetite Loss trials